Effect of Transcutaneous Auricular Vagus Nerve Stimulation on Postoperative Opioid Consumption in Patients Undergoing Major Abdominal Surgery

Affiliated Hospital of Jiaxing University

Status: Not yet enrolling

Conditions: Pain Management

Treatments: Device: Sham Transcutaneous auricular vagus nerve stimulation; Device: Transcutaneous auricular vagus nerve stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT07260266

2025-LP-778

Details and patient eligibility

About

This study aims to design a prospective, double-blind, randomized controlled trial to compare the effects of transcutaneous auricular vagus nerve stimulation (taVNS) on postoperative visceral pain in patients undergoing major abdominal surgery. Participants will be randomly assigned to receive either taVNS or sham stimulation. The total consumption of opioids and other analgesics within 24 hours post-surgery in the AICU will be recorded, along with follow-up assessments of pain scores and quality of recovery scores (Qor-15) at 24 hours postoperatively.

Enrollment: 108 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age between 18 and 85 years, regardless of gender
• ASA physical status classification I-III
• Scheduled for elective major abdominal surgery under general anesthesia, with postoperative admission to the AICU for monitoring
• Anticipated duration of stay in the AICU is approximately 24 hours

Exclusion criteria

• History of vagus nerve-related diseases (such as vasovagal syncope);
• Severe arrhythmias or implanted electronic devices such as pacemakers;
• Skin lesions, infections, or deformities at the site of external ear stimulation;
• Long-term preoperative use of opioid medications or sedatives;
• Allergy to study-related medications;

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

108 participants in 2 patient groups, including a placebo group

transcutaneous vagus nerve stimulation(taVNS)

Active Comparator group

Description:

Patients received taVNS treatment immediately upon entering the AICU, with sessions occurring every 2 hours. A specialized taVNS stimulator device was used, and the left ear was cleaned with an alcohol swab or wet tissue before inserting an earplug with electrode contacts into the left ear, ensuring a snug fit. A second earplug was inserted into the right ear. The stimulation parameters were set as follows: continuous wave, frequency 20 Hz, pulse width 200 μs. Each treatment session lasted for 30 minutes.

Treatment:

Device: Transcutaneous auricular vagus nerve stimulation

Sham-stimulation

Placebo Comparator group

Description:

The treatment protocol was identical to that of the taVNS group. Electrodes were placed on the left auricle. After the device was activated, it either did not deliver any current or only emitted a brief sub-threshold current to simulate the sensation of device activation, without producing continuous neural stimulation.

Treatment:

Device: Sham Transcutaneous auricular vagus nerve stimulation